After spring break, coronavirus cases appear to surge in young Floridians

 Only a week or two after widely shared videos showed crowds of teens and twentysomethings partying on South Florida's beaches, health officials are finding a surge of coronavirus infections in younger people.

Half of COVID-19 cases dated March 1 were found in people 39 or younger, but that median age has since dropped to 35.

Florida remains the nation's hot spot for the more infectious mutations of the viral pathogen, federal data shows. Health-care workers have found 1,075 as of Friday — 1,042 of which are the so-called British strain — according to the latest data available from the U.S. Centers for Disease Control and Prevention. And that is an undercount, as many such cases go unreported because they go untested.

The state health department does not publish up-to-date information on how many variants have been found across Florida.

But data shared March 17 showed that 36% of mutations were found in Broward County, another 15% in Miami-Dade County and 9% in Palm Beach County.

Florida health officials logged 2,039,062 COVID-19 cases as of Saturday, a 5,883-person increase from the day prior.

It's the fifth straight day the state has documented more than 5,000 new infections as cases rise post-spring break.

Palm Beach County logged 130,358 infections as of Saturday, a 454-person increase from Friday.

Florida's death toll stood Saturday at 33,783, a 27-person increase from Friday, and in Palm Beach County, 2,687, unchanged from the previous day.

Nationally, more than 30.2 million people have been infected with the coronavirus since the beginning of the pandemic, and more than 548,000 people have died, according to Johns Hopkins University's coronavirus tracker. 

Tests show the virus continues to surge in Florida, with 6.3% of 90,742 newly released tests coming back positive statewide, along with 6.6% of 6,609 in Palm Beach County, a report published Saturday by the state health department shows.

An average of 5.9% of tests over the past two weeks have come back positive, above the 5% recommended by health experts, who say the positivity rate should remain below that level before the virus can be considered under control. 

State health reports show that has not happened since October.

While partygoers threaten to cause another wave of infections statewide, vaccines continue to make their way into people's arms.

Health-care workers have injected 2,865,665 people with the Moderna and Pfizer booster shots, and 209,668 with the Johnson & Johnson formula, fully inoculating 3,075,333, with 2,528,950 more people awaiting their second dose of the two-shot vaccine.

About 13.7% of Florida's nearly 21.5 million residents have been fully immunized, while another 12% have yet to receive their booster shots. 

People as young as 40 will become eligible to be vaccinated starting Monday, Gov. Ron DeSantis has ordered, and everyone 18 and older will be able to get shots starting April 5.

The Palm Beach County Health District replaced its old vaccine scheduling website Saturday with a new one at vaccine.hcdpbc.org, meant to be easier to use and faster.

Vaccine hopefuls can schedule an appointment at the South Florida Fairgrounds, the South County Civic Center on 16700 Jog Road west of Delray Beach, or the Burns Road Community Center on 4404 Burns Road in Palm Beach Gardens.

https://www.palmbeachpost.com/story/news/2021/03/27/median-age-covid-19-cases-florida-has-now-fallen-35/7030775002/

EMA: Ongoing study data of Celltrion’s mAb enough to allow use in some Covid-19

 The European Medicines Agency added another monoclonal antibody to the continent’s Covid-19 therapeutics arsenal on Friday, concluding that Celltrion’s regdanvimab can be used as a treatment for adults with Covid-19 who do not require supplemental oxygen and who are at high risk of progressing to severe Covid-19.

The EMA said its recommendation is based on a review of data from the first part of an ongoing study showing regdanvimab may lower the rate of hospitalizations in adult outpatients with Covid-19 symptoms described as mild to moderate who do not need supplemental oxygen.

“However, the results were not robust enough to reach a firm conclusion on the medicine’s benefits at this point in time,” EMA said. “In terms of safety, most side effects reported were mild or moderate. Reactions related to the infusion (including allergic reactions) cannot be excluded and healthcare professionals should monitor patients for these reactions.”

Despite the uncertainties, EMA concluded that regdanvimab can be considered a treatment option for patients at high risk of progressing to severe Covid-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.

Celltrion said in February that its mAb, also known as CT-P59, reduced the rate of progression to severe Covid-19 by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over.

A global Phase III clinical trial is still recruiting and is expected to enroll 1,172 patients with mild-to-moderate symptoms of Covid-19 at more than 10 global sites to evaluate the efficacy and safety of the treatment.

While the antibody treatment is currently not authorized in the EU, the EMA’s recommendation on Friday provides a harmonized scientific opinion at the EU level to support national decision making on the possible use of it. A rolling review by the EMA for regdanvimab, which started in late February, is ongoing and will be the basis for a marketing approval, the agency said. The US FDA has yet to authorize the Celltrion monoclonal antibody.

Celltrion also said the Korea Disease Control and Prevention Agency has assessed and independently confirmed that the mAb successfully neutralizes the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of the novel coronavirus. They also said that a cocktail therapy of CT-P59 with another mAb candidate demonstrated neutralizing capabilities against the variants originating in the UK and South Africa (B.1.351).

https://endpts.com/ema-ongoing-study-data-of-celltrions-mab-enough-to-allow-its-use-in-some-covid-19-patients/

Here Come The Global Vaccine Passports

 Vaccination passports are being called the new "golden ticket" needed for global travel - and the hospitality industries that benefit - now that the recovery is on its way.

Countries like Greece, who get a sizeable share of their country's GDP from tourism, are looking forward to welcoming back visitors. Greece will re-open itself to visitors on May 14, Bloomberg noted last week, but will require either a vaccination, proof of recovery from the virus of a negative test before departing for the country. 

Those who require tourism for their livelihoods are ready to move on. Rental boat operator Panagiotis Mastoras said: “It’s the safest way. We’ve reached a point where it can’t go on like this.”

Greece is leading the way in pushing for vaccine passports - usually taking the form of certificates or digital cards - an idea that is also catching on in tourist nations like Thailand and the Caribbean. For businesses who rely on tourism, the "passport" is seen as a "route to salvation", the report notes.

Air travel could win up losing $95 billion in 2021 after 2020's worst year on record. As a result, airlines are following suit in supporting ideas that can get people traveling again. 

“We’re pinning our hopes on the vaccines and the Covid pass,” hotel manager Jorge Marichal, who operates in the Canary Islands, said.

Jeffrey Goh, who heads the Star Alliance of 26 carriers including Air China, Deutsche Lufthansa, Singapore Airlines, and United Airlines Holdings, told Bloomberg: “There has been a lot of advocacy, but the execution has been sorely lacking.” He believes a single set of standards needs to be developed for most major carriers and countries.

Singapore Airlines and Qatar Airlines have both started trials of passport apps, while Carnival Cruiselines has said no one can board its ships without proof of vaccination. American Airlines has started experimenting with the VeriFly app (as has Hyatt Hotels) and United has developed its own app that allows passengers to upload their vaccination records. 

In the EU, on March 17, a "Digital Green Certificate" was given the green light. It could take up to 3 months before it is implemented and can be used. 

But the devil is in the details. Aside from the obvious critique of globalization and overreaching government and corporations getting their noses in your medical records, the vast array of vaccines - some of which have been approved in limited amounts of counties - could make it tricky to determine who is "safe" to travel and who isn't. The passports are also simply unfair, as they "would inevitably favor the inhabitants of richer nations over poorer ones where the distribution of shots has barely begun," the report notes.

Bill Barnett, founder of hospitality consultants C9 Hotelworks Co., thinks the damage is psychological, more than anything: “It’s a case of needing to win over hearts and minds. There’s still a fear factor out there.”

And the Virginia-based Global Business Travel Association, which oversees more than $345 billion, has simply said that the White House should resist any moves that further cripple air travel.

https://www.zerohedge.com/markets/here-come-global-vaccine-passports

'Reservoir of disease' in youth challenges Washington state reopening plans

 An analysis of Washington state Department of Health data—published after peer review March 24—has found that people under 40 years old have continued to become infected by the coronavirus at increasing rates even as the incidence of infection among older populations declines. The publication was available previously in preprint form on medRxiv.

The study led by Judith Malmgren, affiliated epidemiologist in the UW School of Public Health, postulates that the increased spread of the virus among young people "creates a possible reservoir of disease with spillover risk to more vulnerable older persons."

Consequently, Malmgren said, it's a mistake right now for Washington and other states to relax restrictions meant to contain the pandemic.

"We are going to have a spike in four weeks' time. But it won't be as big a spike or as visible a spike as in January because people in older age groups are vaccinated now and so won't be going to the hospital," Malmgren said. "So, we'll be living in a fool's paradise thinking that we don't have a lot of COVID-19 out there when we do."

When the pandemic first erupted, testing found a preponderance of disease among people over 40 who were more likely to show symptoms of the disease and be hospitalized. However, as "hospitalization rates declined without an equivalent rate of decline among confirmed COVID-19 cases," the researchers write, the shift from older to younger populations experiencing disease illustrated "the absence of a true decline in cases."

Following are quotes by Malmgren related to the results of the study:

"It's very hard for people to get it out of their heads that the only people affected were old people. That was wrong, right from the beginning. You can see in our study how quickly the cases became predominantly among 20- to 39-year-olds. And that while the cases went down in 40- to 59-year-olds, they went steadily up in zero- to 19-year-olds.

"The number of cases among 60- to 79-year-olds and among 80-plus-year-olds are dropping now that people are getting vaccinated, but the numbers are going up in zero- to 19-year-olds and in 20- to 39-year-olds. So, it's really a big mistake to go to Phase 3 (the level of reopening designated by Washington).

"It's going to be really, really hard on the state.

"The elderly population was a harbinger of the disease, because they are more susceptible to poor outcomes. While young people are less likely to be symptomatic and require hospitalization, they spread it like crazy.

"As an epidemiologist, you ask where is the disease? In Washington state, it's among people under 40. Since submitting the paper for publication, the trend hasn't changed. And in fact, the number of infections among those younger age groups continues to increase."

More information: Judith Malmgren et al. Continued proportional age shift of confirmed positive COVID-19 incidence over time to children and young adults: Washington State March—August 2020, PLOS ONE (2021). DOI: 10.1371/journal.pone.0243042

https://medicalxpress.com/news/2021-03-reservoir-disease-young-population-washington.html

UAE firm to manufacture Chinese Sinopharm vaccine from April

 A firm based in the United Arab Emirates will start commercial production of China’s Sinopharm vaccines in April, under a deal announced on Sunday.

Gulf Pharmaceutical Industries PSC, based in the emirate of Ras al-Khaimah, signed the deal with Abu Dhabi-based artificial intelligence and cloud computing company Group 42 (G42), which handled Phase III late-stage clinical trials of a Sinopharm vaccine in the UAE and the wider region.

The announcement is an expansion of Chinese diplomacy in the Gulf region and helps the UAE’s quest to diversify its economy away from hydrocarbon production.

Chinese Foreign Minister Wang Yi has just completed a two-day official visit to the UAE, saying Beijing wanted to work with the UAE on producing affordable COVID-19 vaccines.

According to a Julphar filing on the Abu Dhabi stock exchange, the manufacturing agreement was made between Julphar and G42 Medications Trading.

G42 has previously said it has distribution and manufacturing agreements with Sinopharm and hopes to provide the UAE and other states in the region with the vaccine. G42 did not immediately respond to a request for more details.

The government of Ras al-Khaimah owns 12.24% of Julphar, according to Refinitiv data.

G42 began Phase III clinical trials of the vaccine developed by the Beijing Institute of Biological Product, a unit of Sinopharm’s China National Biotec Group (CNBG), in July.

The UAE approved the vaccine for certain groups in September before making it available to the general public.

It has said the vaccine has 86% efficacy, while the Chinese developer has claimed 79.34% efficacy based on an interim analysis of late-stage trials.

Some people in the UAE failed to develop antibodies after a second dose of the Sinopharm vaccine and were given a third dose, the health ministry said this month. It said the number was “minimal” compared to the number of vaccines administered.

https://www.reuters.com/article/us-health-coronavirus-emirates-china/uae-firm-to-manufacture-chinese-sinopharm-vaccine-from-april-idUSKBN2BJ0H3

Facebook: A Worthy Judge of Medical Info?

 Over the past few months, Facebook has used third-party fact-checkers to decide which COVID-19 news stories and op-eds are false or misleading. Recently, one determined that a Wall Street Journal opinion article by Marty Makary, MD, MPH, Johns Hopkins professor and editor-in-chief at MedPage Today, was misleading. Specifically, "Three scientists analysed the article and estimate its overall scientific credibility to be very low," according to HealthFeedback.org, Facebook's checker in this instance.

In his op-ed, Makary argued that COVID-19 will be mostly gone by April. I want to be clear: I am not interested in litigating Makary's opinion, which is what an op-ed conveys. April 30 will be here soon, and we will find out. Instead, I am interested in thinking about how an $800-billion company decides when an op-ed by a professor can be stamped "misleading."

How does this third-party fact-checking system work? Does it solicit reviews from the top academics in a field or discipline? Why is it targeting an op-ed? As I researched this piece, I discovered that the process is obscure. However, what was clear is who the reviewers are.

They are disproportionately academics on Twitter who have mega-follower counts. They mostly have similar worldviews, and advertise those views on Twitter. In a different case, a reviewer already tweeted criticism of the article before being selected as a "fact-checker." This isn't an independent or fair process -- it is cherry picking criticism from Twitter celebrities in order to extinguish dissenting opinions.

How it works

Facebook has asked HealthFeedback.org to fact-check at least some articles. The website appears to solicit between two and four reviewers per article, and compiles their feedback before rendering a verdict. The website appears to be new. It lists three article reviews prior to COVID-19 and seven after. There were 10 reviewers pre-COVID-19, and 19 since January 2020. I extracted data on all reviews.

Fact-checkers or Twitter celebrities?

Of the 19 fact-checkers selected since the start of COVID-19, 15 (79%) have active Twitter accounts. These folks are followed by an average of 42,000 followers (median 10,000). Four of the fact-checkers have served on more than one occasion.

Let's compare the COVID-19 reviewers against pre-COVID-19 fact-checkers and academics in general. Among the 10 fact-checkers for three reviews on HealthFeedback.org prior to COVID-19, there were no repeating reviewers. Half were on Twitter and their average follower count was 442 (median 130).

To compare these rates against average academics, I visited the Johns Hopkins University Department of Epidemiology faculty listing. I picked 10 academics and searched for their Twitter accounts. Just three of the 10 had Twitter accounts with an average following of 800 (median 120).

This should come as no surprise: the average scientist is not on Twitter, including many of the best and brightest. Yet, for pandemic fact-checking, HealthFeedback.org seems to choose from Twitter celebrities who average 40,000 followers.

The independent fact-checkers used by this website appear to be far more active than the average epidemiology faculty member on Twitter. Several have stated their thoughts on COVID-19 policy and support for continued restrictions, while Makary is suggesting we should begin planning to loosen restrictions.

No matter how anyone feels about who is right -- is this a fair process? They are reviewing an opinion article using scientists who are disproportionately on a website that allows them to advertise their opinion in advance. I promise you, I can search Twitter and find three people who will review Makary positively and three who will review him negatively, just by perusing one's past tweets.

A conflict of interest

In one case, it appears the fact-checker was chosen because he had already written a Twitter thread that was critical of the article. The review notes it was "lightly edited for clarity." In other words, a Twitter user announced they were critical of an article, and then their views were selected as independent fact-checking. That is a deeply problematic selection process, as independence typically implies a reviewer has not pre-judged the material.

This also appears to run counter to the process stated where the editor selects the article before choosing reviewers. Imagine if a juror was selected in a trial because they previously tweeted they were sure the defendant is guilty.

It all begins and ends on Twitter

The fact-checking summaries show a larger debt to Twitter. The article that dissects the Wall Street Journal op-ed by Makary also includes screenshots of tweets by Eric Topol, MD, and Caitlin Rivers, PhD, to bolster its claim. Thus, in addition to heavy reliance on academics who happen to be on Twitter as fact-checkers, it appears the editors are closely following the comments on Twitter to guide them, perhaps even toward which topics to select.

This is not independent fact-checking, but groupthink

Put together, the fact-checking is suspect. It appears to be a website with its own policy ideas about COVID-19, which is selecting academics who are popular on Twitter, and have declared a point of view -- and gives them the chance to extinguish ideas that oppose their own.

It feels like a high school clique. These are the popular kids. They are using their position to label views they disagree with as "misleading."

Some argue this is just the battle of ideas, just a debate. Debate would be if these reviewers wrote a rebuttal, but they go further. They use the brute force of the platform to literally label Makary's op-ed as misleading. That is a massive leap from debate. Labeling instantly usurps the reader of their ability to make up their own mind. It is antithetical to the spirit of the academy.

Facebook is a sea of garbage and this is what they police?

I have to state the obvious: Facebook is a sea of garbage. Illogical arguments, false claims, harmful views -- you can open Facebook and find whatever objectionable idea you wish. That's why I don't open it. And yet, there is only a tiny subset of stories that the organization has sought to label "misleading." And one of them is an op-ed by Makary? This whole scenario is bizarre!

Meanwhile, there are news stories that are patently wrong for which Facebook takes no action.

What I didn't find

I did not find any explanation as to which of the billions of articles and Facebook posts the fact-checkers are asked to review. How does the editor pick? I found only a vague explanation of the standard to judge an article, not how disputes among reviewers are handled. I did not find an explanation of how the reviewers are chosen and what happens if they decline. I did not find information regarding who is paying whom and how much. I did not find evidence of how appeals are handled.

This is an op-ed

I again have to mention the Kafkaesque point that Makary's piece is an op-ed, which by definition is his perspective based on his interpretation of data. Much like a Franz Kafka novel, Makary has gotten a show trial by Facebook, and is found guilty of misleading the public with his opinion article by a bunch of Twitter celebrities, whose opinion is well known. I don't know if Makary is right or wrong, and time will tell, but what I do know is this process is not acceptable or fair. Facebook should not call it "fact-checking." That's not right. It is just checking what their friends on Twitter have to say.

Vinay Prasad, MD, MPH, is a hematologist-oncologist and associate professor of medicine at the University of California San Francisco, and author of Malignant: How Bad Policy and Bad Evidence Harm People With Cancer.

https://www.medpagetoday.com/blogs/vinay-prasad/91526

Sinopharm needs trial results to decide if COVID-19 vaccine needs booster

 China National Pharmaceutical Group (Sinopharm) will need to assess results from overseas Phase III clinical trials to decide whether its two-shot COVID-19 vaccine should be followed by a booster shot, a company executive said on Sunday.

Regulators and vaccine developers are looking at whether booster doses are necessary amid concerns that emerging variants of the new coronavirus might weaken protection of vaccines designed against older strains.

“The preliminary results so far showed that the booster vaccination can effectively increase the neutralizing antibody titer and antibody persistence, and also effectively improve the vaccine’s ability to resist mutations,” Zhang Yuntao, vice president at China National Biotec Group (CNBG), an affiliate of Sinopharm, said on Sunday.

“Is a booster shot needed? When will the booster be given? The answer should be based on the results of future phase III clinical studies,” Zhang said at a news conference.

Antibodies triggered by two COVID-19 vaccine products from Sinopharm both have “pretty good” neutralising effect on variants found in Britain and South Africa as well as a few others, Zhang told a news conference, citing results from lab tests using blood samples taken from clinical trial participants.

Lab testing was ongoing for variants found in Brazil and Zimbabwe, Zhang said.

The effect of antibodies induced by Sinovac Biotech’s vaccine declined against a variant identified in South Africa, while the effect against a variant found in Britain remained similar to that against the older Wuhan variant, Gao Qiang, general manager at Sinovac unit Sinovac Life Sciences, said during the same presser.

Sinovac is importing the variant from Brazil for vaccine research and development, and work tailored to the South Africa variant had already started, Gao said.

The correlation between antibody levels and the vaccine’s efficacy was not immediately clear, a Sinovac spokesman said.

Sinovac was also testing a third booster shot in a China-based clinical trial, with participants given a third dose around eight months after receiving the second, the company said on Tuesday.

The South Africa variant could pose a greater threat than others based on antibody responses triggered by the vaccine from CanSino Biologics Inc (CanSinoBIO), a company executive said earlier this month. Antibodies triggered by one dose of CanSinoBIO’s vaccine showed a roughly four-fold drop in their ability to block the 501Y.V2 variant, the firm’s chief scientific officer, Zhu Tao, said. The weakening effect by other variants fell into a less severe range, he added.

https://www.reuters.com/article/us-health-coronavirus-vaccine-sinopharm/sinopharm-needs-trial-results-to-decide-if-covid-19-vaccine-needs-booster-shot-executive-idUSKBN2BK05Q